Breaking news from Stockholm, Sweden, where our team is on the ground at the European Association for the Study of Diabetes (EASD) Conference – one of the largest diabetes conferences of the year. Lilly/BI just announced the groundbreaking results from their major clinical trial (called EMPA-REG) on Jardiance (aka empagliflozin), an SGLT-2 inhibitor pill for type 2 diabetes (see the accompanying announcement, live web-stream, and publication in the New England Journal of Medicine). We learned last month that Jardiance is now the first modern-era diabetes drug shown to improve heart safety in patients at high risk for heart problems. Today, we learned just how much of an improvement this drug actually can deliver. When added to the “standard of care” (best possible regimen) in patients with type 2 diabetes who are at high risk of heart disease, Jardiance led to:

In addition, the incidence of diabetic ketoacidosis was less than or equal to 0.1% in all treatment groups, and there was no increased risk with Jardiance. The Jardiance group also saw no added risk of bone fracture - a timely finding, as the FDA just recently put out a Drug Safety Communication about bone fracture risk with Invokana (another SGLT-2 inhibitor) that we assume was designed to assess class risk.

The trial observed over 7,020 adults with type 2 diabetes at high risk for cardiovascular problems taking Jardiance in addition to the "standard of care" for heart disease risk reduction (e.g., statins, blood pressure lowering drugs, aspirin, etc.) and diabetes care (most participants were taking other diabetes medications as well). While this study only observed Jardiance in particular, it’s possible or likely that other SGLT-2 inhibitor drugs (Invokana and Farxiga) may show similar effects – potentially paving the way for this drug class to become the standard second-line treatment for type 2 diabetes (after metformin) farther down the road. Both Invokana and Farxiga are undergoing their own “cardiovascular outcomes trials” to examine their own effects on heart health, with results to be completed in 2017 and 2019, respectively.

With as many as 65% of people with diabetes dying from some form of heart attack or stroke, these results reflect the potential to prevent millions of deaths from heart disease in people with diabetes, marking unbelievable news for patients, healthcare providers, and the healthcare system as a whole. Onward! We’ll be back with more information and please let us know your questions!